21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO THE MAESTRO SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
FDA 510(k)
FDA Class 2
·Anesthesiology
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 25, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 21, 2006
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·March 15, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 27, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 27, 2013
MICRO INCISION VACUUM PHACO PACK
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQC·July 10, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·March 28, 2008
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·February 4, 2019
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2018
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2019
7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the open design of the system, the Signa 0.7T Signa OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles. . .
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015